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Investigation of the Effects of Diet on the Measurement of Plasma Chromogranin in NET Patients

NCT03288402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2024-06-20

No results posted yet for this study

Summary

Measurement of plasma chromogranin A remains the most commonly used biomarkers for both screening and monitoring of patients with gastro-entero-pancreatic neuroendocrine tumours (GEP-NET), despite several limitations that include: lack of a reference CgA standard; wide variations depending on the used assay in different laboratories; and varying sensitivity ranges from 60 to 90% with low specificity \<50%, depending on the population studied.

Surprisingly, and to the best of our knowledge, only three studies with small numbers of participants have been published that have investigated possible effects of food intake on the measurement of CgA. Most have been performed in healthy controls or patients on treatment with proton pump inhibitors for chronic gastritis (up to n = 11 per group) but only one study has investigated patients with GEP-NET, where n = 6 patients with gastric NET were included.

In this study, the investigators aim to assess the time dependent effects of normally ingested diet (5-item English breakfast; or tea or coffee; or ongoing fasted state) on plasma chromogranin A measurements, using timed measurements over 180 min following an \> 10 hours overnight fast, in a randomised double-crossover design. The investigators aimed to include 25 - 35 patients with a histologically confirmed diagnosis of a GEP-NET of varying primary tumour location, tumour stage, grade; and presence or absence of treatment with long acting somatostatin analogues; as well as 10 - 15 healthy controls. In an additional small subgroup of patients who are initiated on treatment with GLP-1 analogues i.e. for type 2 diabetes or obesity, the investigators aim to establish whether injection of GLP-1 analogues has any effects on plasma CgA measurements.

Conditions

Interventions

OTHER

ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast

effects of ongoing fasted state; or intake caffeine containing beverages; or 5-item English breakfast on plasma CgA measurements, in series blood tests every 30 min over 180 min

Sponsors & Collaborators

  • University Hospitals Coventry and Warwickshire NHS Trust

    lead OTHER

Principal Investigators

  • Martin O Weickert, Professor · The ARDEN NET Centre, ENETS CoE

  • Megan Symington, Dr · The ARDEN NET Centre, ENETS CoE

  • Helen Robbins, Dr · The ARDEN NET Centre, ENETS CoE

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2021-08-10
Completion
2022-02-10

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03288402 on ClinicalTrials.gov